The agency approved the monoclonal antibody for patients whose psoriasis did not respond to previous systemic therapy or stopped responding to the therapy and who are otherwise candidates for systemic therapy or phototherapy. The approval came with the requirement for a boxed warning and availability through a restricted program because of episodes of suicidal ideation and suicides seen during the agent's clinical trials.

"Moderate-to-severe plaque psoriasis can cause significant skin irritation and discomfort for patients, and today's approval provides patients with another treatment option for their psoriasis," Julie Beitz, MD, director of the FDA Office of Drug Evaluation III, said in a statement. "Patients and their healthcare providers should discuss the benefits and risks of Siliq before considering treatment."

Support for the approval came from three randomized, placebo-controlled trials involving a total of 4,373 adults with moderate-severe plaque psoriasis. The trials demonstrated significantly higher rates of clear or nearly clear skin among patients treated with brodalumab versus placebo.

In taking the action, the FDA followed the recommendation of an advisory committee that voted in favor of approval last summer, despite FDA staffers' concerns about the suicidal ideation and suicide, which were limited to brodalumab users who had a history of suicidality or depression.

Access to brodalumab will be through a Risk Evaluation and Mitigation Strategy program that has prescriber and pharmacy certification requirements, as well as a patient-prescriber agreement form.

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